Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
VERAPAMIL HYDROCHLORIDE
Abbott Laboratories Ireland Ltd
240 Milligram
Prolonged Release Capsules
2005-07-27
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Isoptin SR 240 mg Prolonged-Release Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Isoptin SR Prolonged-Release tablet contains 240 mg Verapamil Hydrochloride. Excipients: Each prolonged release tablet contains up to 32mg (1.39mmol) Sodium. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Prolonged-release film-coated tablet The oblong tablets are film-coated and light green colour, with a breakline on both sides and the Knoll logo on one side.The tablets can be divided into equal halves but must not be crushed or chewed. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Isoptin SR 240 mg Prolonged Release Tablets are indicated in the treatment of mild to moderate hypertension and coronary heart disease, i.e. prophylaxis of myocardial ischaemia, angina pectoris. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. _Hypertension: _The adult dose is one tablet (240 mg) in the morning, increasing if necessary after one week to 240 mg in the morning and 240 mg in the evening, with an interval of 12 hours. In elderly patients, the initial dose is half a tablet (120 mg) in the morning, increasing by 120 mg increments at weekly intervals according to patient response. _Angina pectoris: _The usual dose is 120-240 mg twice daily according to patient response. It is recommended that low initial doses with upward titration are used in new patients. Verapamil should not be taken with grapefruit juice (see interactions). In patients with impaired liver function, metabolism of the drug is delayed to a greater or lesser extent depending on the severity of hepatic dysfunction, thus potentiating and prolonging the effects of verapamil hydrochloride. Therefore, the dosage need Læs hele dokumentet